Additional file 2. List of key methodological items in reviewing the EEs of biomarker-guided therapies
Question items Yes No
Q1. Did the EE include all patient groups regardless of their biomarker status (test positive, negative, unknown)?
Q2. Did the EE justify the viewpoint of analysis? (i.e. Analysis perspective; third-party payer, society, hospital, etc.)
Q3. Was the standard of care chosen as a comparator strategy?
Q4. Was the test-treat strategy compared to the comparator strategy arm(s)?
Q5. Was the clinical effectiveness of the companion biomarker test considered in the economic models? If not considered, justification/assumption provided?
Q6. Were preference-based outcomes of companion biomarker tests were considered in the economic models? If not considered, has the assumption been provided with justifications?
Q7-1. Were the details of the resource consequences of the use of companion biomarker testing considered and reported?
Q7-2. Were the costs of companion biomarker test(s) considered and reported?
Q8. Different timing of the test(s) was considered and reported? (i.e. at the time of diagnosis, at the time point of progression to metastasis, etc.)
Q9. Was uncertainty with respect to the characteristics of the companion biomarker test(s) explored? (i.e. at least one component of the characteristics of biomarker test was tested; such as cost, cut-off threshold, sensitivity/specificity)
Q10. Were the data sources for the model inputs clearly reported and justified? (i.e. meta- analysis, clinical trials, published papers, etc.)
Q11. Was the name/type of biomarker test specified? (e.g. Cobas® BRAF V600 mutation test) Q12. Was the frequency/prevalence of biomarker status considered in the economic model? If not, has this been justified?
